Registration Dossier
Registration Dossier
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EC number: 423-870-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-04-26 to 1994-04-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- body weight was not measured at the conclusion of the test; description of any other toxic effects besides skin reactions were not recorded.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1994-03-16
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Details on test material:
- - State of aggregation: cream coloured powder
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.49 - 2.56 kg
- Housing: individually housed in suspended metal cages
- Diet (ad libitum): STANRAB SQC Rabbit Diet
- Water (ad libitum): mains drinking water
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 23 °C
- Relative humidity: 51 - 59 %
- Air changes: approx. 15/hour
- Photoperiod (hrs dark / hrs light): 12:12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test material moistened with 0.5 mL of distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: skin area on the back was clipped
- Type of wrap if used: test item was introduced under a 2.5 cm x 2.5 cm gauze patch, which was secured with a strip of surgical adhesive tape (BLENDERM). Furthermore, each animal was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing: test material removed by gently swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- approx. 1 hour as well as 24, 48 and 72 hours after removal of the test material
SCORING SYSTEM:
- Method of calculation: according to the Draize scale
Any other skin reactions were also recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal No. 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal No. 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal No. 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal No. 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal No. 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal No. 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin reactions were noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
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